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Last Updated: November 22, 2024

LABETALOL HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for labetalol hydrochloride and what is the scope of patent protection?

Labetalol hydrochloride is the generic ingredient in five branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience Speclts, Schering, Sebela Ireland Ltd, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Rubicon, Sandoz, Teva, Unichem, Watson Labs, Zydus Pharms, and Alvogen, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for labetalol hydrochloride. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LABETALOL HYDROCHLORIDE
US Patents:0
Tradenames:5
Applicants:24
NDAs:30
Drug Master File Entries: 13
Finished Product Suppliers / Packagers: 40
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 69
Patent Applications: 1,157
What excipients (inactive ingredients) are in LABETALOL HYDROCHLORIDE?LABETALOL HYDROCHLORIDE excipients list
DailyMed Link:LABETALOL HYDROCHLORIDE at DailyMed
Recent Clinical Trials for LABETALOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston Medical CenterPhase 4
Marshall UniversityPhase 2
Loma Linda UniversityN/A

See all LABETALOL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MG/MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LABETALOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for LABETALOL HYDROCHLORIDE

US Patents and Regulatory Information for LABETALOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Steriscience Speclts LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 079134-001 Feb 3, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rubicon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 211953-003 Aug 18, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Heritage Pharma LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074787-001 Aug 3, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-003 Aug 1, 1984 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075113-001 Aug 4, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cadila Pharms Ltd LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 211325-001 May 13, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LABETALOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-002 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Schering NORMODYNE labetalol hydrochloride INJECTABLE;INJECTION 018686-001 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-004 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.